An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer

Completed

• Conditions: Recurrent Ovarian Cancer

• Registration Number: NCT01869400
• Lead Sponsor: PharmaMar, Spain

Brief Summary

Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population.

Especially elderly patients and patients with co-morbidities are underrepresented in clinical trials.

This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD combination therapy in a general patient population to evaluate if the data collected in the clinical trials can be assigned to a general patient population.

Detailed Description

Yondelis® (trabectedin) was approved (in combination with PLD) in the European community in December 2009 for the treatment of platinum-sensitive ovarian cancer relapse. Based on the outcomes of study OVA-301, this non-interventional study will investigate the role of a platinum-free treatment regimen in patients with progressive ovarian cancer relapsing \> 6 months after completing previous platinum-based chemotherapy. In particular, this study aims at collecting the "real-life" data with regard to the response and the influence of the mentioned therapy on the "tumor related events", to objectify the value of palliative care.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-05
• Primary Completion: 2016-12
• Study Completion: 2017-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

Inclusion Criteria

• Women age >18, no upper limit
• Patients with relapsed platinum-sensitive ovarian cancer
• Before inclusion in the NIS written informed consent must be given

Exclusion Criteria

• According to summary of product characteristics

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety and tolerability data of the study therapy	during Yondelis-PLD-therapy	Number of patients with adverse events

Secondary Outcome Measures

Name	Time	Method
Treatment duration	during Yondelis-PLD-therapy	Time between first and last cycle of each patient
Time to next treatment	1 Year after last Yondelis-PLD-Therapy	Date from last Yondelis-PLD-treatment to date of next treatment
Progression free survival	till one year after last date of Yondelis-PLD-therapy	Difference between date of first documentation of "PD" and the date of first Yondelis® + PLD application
"Real life data" - clinical and / or serological (CA 125) response and Stable disease rates	till one year after last date of Yondelis-PLD-therapy	Number of patients with CR, PR, SD as best response
Observation of the number of the therapy cycles applied	during Yondelis-PLD-therapy	Number of applied therapy cycles
Duration of response	till one year after last date of Yondelis-PLD-therapy	Time in months from first assessment of CR or PR until the first date of PD or death.

Trial Locations

Locations (2)

Praxis und Tagesklinik für gynäkologische Onkologie; 🇩🇪 Ebersberg, Bayern, Germany

Diakoniekrankenhaus, Gynäkologie und Geburtshilfe; 🇩🇪 Rotenburg, Lower Saxony, Germany